[102998262]
I am (b)(6) and i am in my second trimester of pregnancy. In (b)(6) i purchased a product from (b)(6) after seeing some videos online. The product is allegedly used by expecting moms to check the safety and health of the baby before birth. Since i had a miscarriage before i thought it could be useful for me. When the package arrived it came along with an ultrasound gel. I did use it at home. I was not able to spot any heartbeat and that was the most panicking first shock. Then i came to know that the device even didn't pick my own heartbeat which that relieved me a bit that the device could be faulty. Anyhow i had tried for 30 minutes to spot the baby's heartbeat. Later on i was searching in the internet forums to find out other used experience. This time i came across some articles and also a warning from fda in regards to the use of this device. This product potentially could harm babies resulting in hearing impairment and birth defects. I consulted with my doctor and she recommended me to contact also fda and the supplier. My husband had communicated the same to (b)(6) customer service but they seem quite negligent to such a major health threat. Still the product can be found here on this link and can be purchased. (b)(6). Apparently this device is being sold as otc for personal use while it seems to be the doctors professional equipment. As an expecting mom i felt panicked disappointment, over anxious. That's the last thing we need with all those hormone imbalances. Thanks for your consideration. This fda link clearly states that the uncontrolled use could expose mom and babies to harm! Https://www. Fda. Gov//forconsumers/consumerupdates/ucm095508. Htm. Another mom forum talking about this: (b)(6).
Patient Sequence No: 1, Text Type: D, B5